the cro-sponsor interaction: regulatory affairs
TRANSCRIPT
The CRO –Sponsor Interaction
Regulatory Affairs
Chris Ingram BSc (Hons)
Director, Regulatory Affairs
OCT Europe – 17 May 2016
‘80s-90’s 2000s Mid 2000s-Present
Consolidation of service offerings:
• Clinical operations
• Biometrics
• Safety
• Laboratories: central,
bioanalytical, biorepository,
imaging
• Therapeutic expertise
• Quality assurance
• Regulatory affairs/study start-
up
• RWE/Late phase
• Medical devices
Risk-based sharing execution models
Expansion of service offerings:
• Project management
• Regulatory affairs
• Scientific affairs
• Medical affairs
• Medical writing
• Clinical operations
• Laboratory services
Adoption of preferred provider lists
by pharma/biotech
Limited service offerings:
• Data management
• Biostatistical analysis
• Clinical site monitoring
Primarily used as additional capacity
by pharmaceutical companies
CRO-Sponsor Interface Evolution
Physician Led | Therapeutically Focused2
Functional Service Provider Preferred Vendor Strategic Partnership
Keys to a Productive Alliance
Transactional: Tactical and
Episodic
Preferred: Tactical and
Repetitive
Partnering: Strategic and
Episodic
Integration: Strategic and
Holistic
Level of Collaboration
Level
of
CRO
Input
Physician Led | Therapeutically Focused3
Keys to a Productive Alliance
Trust Knowledge Collaboration
Physician Led | Therapeutically Focused4
The Vision is the Thing
Physician Led | Therapeutically Focused5
The CRO Regulatory Experience
Seamless Transitions• Across regions
• Throughout development cycle
Objectively Different Focus Up-to-Date Global Perspective
Therapeutic Target Expertise Broad Array of Regulatory
Expertise
Physician Led | Therapeutically Focused6
Key Factors for Positive CRO-Sponsor Relationships
The Sponsor
Shares
Thinking
Shares
Data
Shares
Objectives
Key Factors for Positive CRO-Sponsor Relationships
The CRO
Shares
Intelligence
Shares
Expertise and
Experience
Shares
Perspective
Embraces
the Sponsor
Objective
Physician Led | Therapeutically Focused8
Key Factors for Positive CRO-Sponsor Relationships:
The partnership
Develops Fully
Integrated
Development
Strategy
Communicates
Openly
Executes
with
Consistency
Physician Led | Therapeutically Focused9
Key Factors for Positive CRO-Sponsor Relationships
Regulatory Affairs
Global Understanding
Local Expertise
Technical Mastery
Physician Led | Therapeutically Focused10
What’s Coming – What’s Trending –What’s Challenging
Patient-Centered
Health Care
Outcomes, Surrogates and
Biomarkers
Fast-Track, Accelerated,
and Breakthrough
Novel Populations
Physician Led | Therapeutically Focused11
Early Engagement is Critical
Physician Led | Therapeutically Focused13
